NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as SAREPTA THERAPS INC. It is marketed under 1 brand name, including VYONDYS 53. Available in 1 different strength, such as 100MG/2ML (50MG/ML), and administered through 1 route including SOLUTION;INTRAVENOUS.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"72931","ingredient":"GOLODIRSEN","trade_name":"VYONDYS 53","family_id":"ace4e9f25af94c658299","publication_number":"US10227590B2","cleaned_patent_number":"10227590","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-28","publication_date":"2019-03-12","legal_status":"Expired"} | US10227590B2 Molecular Formulation | 12 Mar, 2019 | Expired | 28 Jun, 2025 | |
| {"application_id":"72932","ingredient":"GOLODIRSEN","trade_name":"VYONDYS 53","family_id":"ace4e9f25af94c658299","publication_number":"US10266827B2","cleaned_patent_number":"10266827","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-28","publication_date":"2019-04-23","legal_status":"Expired"} | US10266827B2 | 23 Apr, 2019 | Expired | 28 Jun, 2025 | |
| {"application_id":"72933","ingredient":"GOLODIRSEN","trade_name":"VYONDYS 53","family_id":"ace4e9f25af94c658299","publication_number":"US10421966B2","cleaned_patent_number":"10421966","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-28","publication_date":"2019-09-24","legal_status":"Expired"} | US10421966B2 Molecular Formulation | 24 Sep, 2019 | Expired | 28 Jun, 2025 | |
| {"application_id":"72935","ingredient":"GOLODIRSEN","trade_name":"VYONDYS 53","family_id":"ace4e9f25af94c658299","publication_number":"US10968450B2","cleaned_patent_number":"10968450","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-28","publication_date":"2021-04-06","legal_status":"Expired"} | US10968450B2 Molecular Formulation | 06 Apr, 2021 | Expired | 28 Jun, 2025 | |
| {"application_id":"72936","ingredient":"GOLODIRSEN","trade_name":"VYONDYS 53","family_id":"ace4e9f25af94c658299","publication_number":"US10995337B2","cleaned_patent_number":"10995337","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-28","publication_date":"2021-05-04","legal_status":"Expired"} | US10995337B2 Formulation | 04 May, 2021 | Expired | 28 Jun, 2025 | |
| {"application_id":"72919","ingredient":"GOLODIRSEN","trade_name":"VYONDYS 53","family_id":"ace4e9f25af94c658299","publication_number":"US9024007B2","cleaned_patent_number":"9024007","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-28","publication_date":"2015-05-05","legal_status":"Granted"} | US9024007B2 Molecular Formulation | 05 May, 2015 | Granted | 28 Jun, 2025 | |
| {"application_id":"72926","ingredient":"GOLODIRSEN","trade_name":"VYONDYS 53","family_id":"ace4e9f25af94c658299","publication_number":"US9994851B2","cleaned_patent_number":"9994851","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-28","publication_date":"2018-06-12","legal_status":"Granted"} | US9994851B2 Molecular Formulation | 12 Jun, 2018 | Granted | 28 Jun, 2025 | |
| {"application_id":"72927","ingredient":"GOLODIRSEN","trade_name":"VYONDYS 53","family_id":"ace4e9f25af94c658299","publication_number":"USRE47691E","cleaned_patent_number":"RE47691","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-28","publication_date":"2019-11-05","legal_status":"Granted"} | USRE47691E1 Formulation | 05 Nov, 2019 | Granted | 28 Jun, 2028 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.